MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T DF-1 PROMRI; CRT-D

Model Number 393013

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

After an implantation period of approx.43 months, it was reported that the device shows the eos status.The patient underwent an mri on the (b)(6) 2021.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the eos battery status, 14 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the inspection of the available iegms noise was observed in the atrial, ventricular and far-field channels of the episodes recorded on (b)(6) 2021.The data further showed, that the device automatically activated the eos battery status on the same day at 11:16 h.The frequency and morphology of the sensed noise signals can be most probably attributed to strong external electromagnetic fields as used by magnetic resonance imaging.The data further showed a detection of strong magnetic fields at 11:05 h, 11 minutes before the eos detection, which is consistent with the mri scan reported in the event description.Analysis confirmed that the mri mode was not activated on (b)(6) 2021.In a next step, the icd was subjected to an electrical analysis.First, a sensing test was performed.The device sensed the attached heart signals free of noise, proving the sensing functions of the icd to be normal.The eos status was removed with a technical programmer and subsequent interrogation showed the device status mos1.The battery voltage of 2.92 v revealed a charged battery.Following, the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached and the charging time was as expected.In addition, the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.Based on the analysis results, the eos status resulted from an mri scan without prior activation of the mri mode.If a charging cycle occurs in a strong external magnetic field, depending on strength and orientation, a saturation of the high voltage transformer may appear, leading to a temporary drop of the supply voltage below the eos level, resulting in the observed eos battery status.This observation does not represent a battery or hybrid malfunction.The analysis did not reveal any indication of a device malfunction.

• Brand Name: ITREVIA 7 HF-T DF-1 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11293334
• MDR Text Key: 230723237
• Report Number: 1028232-2021-00667
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 393013
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization